DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites the steps of denoising the amplified signals; generating an energy spectrogram from the denoised amplified signals and extracting the contours and scaling said contours with a calibration value obtained from a subject, wherein said calibration value is used as a baseline value to obtain the subject's blood pressure values.
The limitation of denoising the amplified signals; generating an energy spectrogram from the denoised amplified signals and extracting the contours and scaling said contours with a calibration value obtained from a subject, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a processor unit”, the claims are directed to concepts relating to organizing information in a way that can be performed mentally or analogous to human mental work and nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the processor, communications interface and output language, “denoising”, ”generating”, “extracting” and “obtaining” in the context of this claim encompasses the user manually calculating a filter function and a transform to determine the harmonics for calculating the blood pressure. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of a sensor unit. The sensor is used for mere data gathering and amounts to insignificant extra-solutional activity, specifically pre-solutional activity. Additionally, the processor unit and processing module which amounts to code are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Similarly the dependent claims do not include additional elements that amount to significantly more. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept and well-understood, routine and conventional activity is not sufficient to amount to significantly more than the abstract idea itself. The claim is not patent eligible.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a sensor unit” and “a computation module” in claim 1 which are a BCG sensor and smart phone, computer or remote server, see ¶25. “a data acquisition unit” and “a conditioning unit” in claim 9 which are processors, see ¶25. “a data receiver module” in claim 10 which is smart phone, computer or remote server, see ¶25. “a transmission unit” and “a wireless technology module” in claim 11 which are a smart phone, computer or remote server and the module is programmed wireless protocol, see ¶26.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 13 recite the contours trend based on the harmonics are determined based on their alignment with changes in blood pressure but the specification does not provide any examples or descriptions of how this is done.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Similarly, the claims recite said energy spectrogram comprising of contours trend but is not clear what this is stating. It is unclear if a trend is determined or if the claim language is simply saying that the spectrogram is made up of contours or contour trends. It is unclear how is the alignment determined and what changes are being aligned with or compared. Examiner presumes the alignment is just the concordance of the reference blood pressure signal, which is not claimed as being collected, with the intensities or contours of the spectrogram. It is not clear if the “a blood pressure measuring device” is a separate device from the claimed system for blood pressure determination. Examiner presumes this is a reference blood pressure device of some type.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parchani et al. US 2021/0127983 in view of Kim et al. “Ballistocardiogram-Based Approach to Cuffless Blood Pressure Monitoring: Proof of Concept and Potential Challenges”
Regarding claims 1 and 13, Parchani discloses a system for blood pressure determination comprising:
a sensor unit configured to record cardiac micro-vibrations as analog signals and convert the analog signal to micro-voltage digital signals ([¶23,24] vibroacoustic sensors which convert micro-vibrations to micro-volt readings);
a processor unit configured to record the micro-voltage digital signals in chronological format and amplify the recorded micro-voltage digital signals to obtain amplified signals ([¶25-27] subsystem 104);
a computation module configured to ([¶35] computation subsystem 120):
de-noise the amplified signals ([¶35] clustering algorithms are used to remove motion noise);
generate an energy spectrogram from the denoised amplified signals, the energy spectrogram comprising of contours based on harmonics that align with changes in blood pressure ([¶40] the signals are put through a STFT to get a spectrogram);
extract the contours from the harmonics ([¶41] the spectrogram is analyzed and features are extracted); and
scale the contours with a calibration value obtained from a subject using a blood pressure measuring device ([¶41] the spectrogram is scaled ).
Parchani does not specifically disclose that the BCG is used to determine blood pressure wherein the calibration value is used as a baseline value to obtain the subject's systolic and diastolic blood pressure values based on a deviation from the calibration value. Kim teaches a similar BCG cardiac monitor that determines blood pressure from the BCG ([pg. 2385, second column) and uses a cuff based calibration value to determine the pressure from the BCG ([pg. 2386, last ¶ of second column and pg. 2387, first ¶ first column above Results] the BCG values are calibrated based on the reference pressure measured with a cuff device and the deviation is used to determine the systolic and diastolic pressures). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Parchani with the teachings of Kim in order to have more parameters to provide to the patient for monitoring their cardiovascular health at home ([pg. 2385]).
Regarding claims 2 and 14, Parchani discloses the recorded micro-voltage digital signals are amplified up to 2500 times ([¶27] 15 to 2500x amplification).
Regarding claims 3 and 15, Parchani discloses the computation module is configured to denoise the amplified signals by filtering the signal to between 0.2 to 40 Hz ([¶31-36] 5-15 Hz is narrower than the claimed range and thus is sufficient to establish obviousness, see MPEP 2144.05).
Regarding claims 4 and 16, Parchani discloses the computation module is configured to denoise the amplified signals using a density based scan clustering algorithm to remove body motion artifacts ([¶35]).
Regarding claims 5 and 17, Parchani discloses the energy spectrogram is generated using Short Term Fourier Transform ([¶40]).
Regarding claims 6 and 18, Kim teaches wherein the calibration value is measured from the subject using a cuff-based device ([pg. 2386, first column] the calibration is based on a finger cuff measurement).
Regarding claims 7 and 19, Parchani and Kim do not specifically disclose the computation module is configured to scale the harmonics trend contours using the double sigmoid activation method. At the time the invention was filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to use a double sigmoid activation method because Applicant has not disclosed that the double sigmoid activation provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the multi variate linear regressions of Kim, and applicant' s invention, to perform equally well with either the linear regression taught by Kim or the claimed double sigmoid activation method because both functions would perform the same function of scaling the signal equally well.
Therefore, it would have been prima facie obvious to modify Parchani and Kim to obtain the invention as specified in the claim because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Kim.
Regarding claim 8, Parchani discloses the processor unit and the computation module are combined in a single processor ([¶67] a computer system of FIG. 10 can implement the various embodiments and components).
Regarding claim 9, Parchani discloses the processor unit comprises a data acquisition unit configured to record the micro-voltage digital signals in chronological order and a conditioning unit configured to amplify the recorded signals to obtain an amplified signal ([¶26,28,52]).
Regarding claim 10, Parchani discloses wherein a data receiver module stores the amplified signals, said data receiver module is a smartphone, a computer or a remote cloud server ([¶67-68] communications channel 1008 on computer 1002).
Regarding claim 11, Parchani discloses a transmission unit comprising a wireless technology module transfers the amplified signals to the data receiver module ([¶67-68] communications channel 1008 on computer 1002).
Regarding claim 12, Parchani discloses the computation module is a smartphone, a computer or a remote cloud server ([¶67-68]).
Response to Arguments
Applicant's arguments filed 4/2/26 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments against the 101 rejection, Examiner respectfully disagrees. Applicant argues that a person could not mentally process physiological sensor signals, generate a spectrogram and process specific information from the spectrogram, Examiner disagrees. A person could with aid of pen and paper process the physiological signal data to generate a spectrogram by calculating the Fourier transform and then from the resulting data determine further information. The claim does not require that the calculations are performed in real-time or any specific time frame that the person could not possibly achieve.
Regarding Applicant’s argument against the step 2B analysis, Examiner respectfully disagrees. Specifically, the claims do not recite significantly more. The use of a subject- specific calibration obtained from a blood pressure device is still part of the judicial exception that falls under the Mental Process category. Additionally, Applicant argues that the claims recite a particular inventive technology that is an improvement over existing blood pressure measurement systems but further reasoning and arguments, other than the statement the claims improve the technology, are not provided.
Regarding Applicant’s arguments against the claim interpretation under 112(f), Examiner respectfully disagrees. The terms unit and module are generic placeholders only modified by broad terms like computing and conditioning and their functions. As such they are treated under 112(f). Even though they map to a sensor and a smart phone and processors does not mean that the claim language provides enough structure on its own to obviate the 112f interpretation.
Regarding Applicant’s arguments against the 112b rejections, Examiner respectfully disagrees. What the contours are is now clear. They are the intensities of the frequencies in the spectrogram but what is still not clear is what is meant by “the harmonics align with changes in blood pressure”. It is unclear if this is just a statement of fact that the harmonics by their nature line up with the changes observed in a time domain blood pressure signal or if there is an actual alignment happening. It is noted that the blood pressure signal is not recited as being collected.
Regarding Applicant’s arguments against the 103 rejection, Examiner respectfully disagrees. Parchani performs the same STFT to get a spectrogram that is then analyzed to determine hemodynamic parameters. The fact that Parchani uses a CNN for further classification is not pertinent to the determination that discloses the claimed elements, nothing in the claim language precludes the additional features and functions of Parchani. The extracted spectrum of Parchani contains the same information as the claimed spectrogram. Applicant argues that the role of the spectrograms is different in Parchani than the claimed invention but this is not the case. Nothing in the claim language requires or states that the spectrogram is the final determination. Both Parchani and the claimed invention use a spectrogram as part of their analysis to determine hemodynamic parameters.
Regarding Applicant’s argument against Park, Examiner respectfully disagrees. A reference teaches a device with additional sensors as part of its determination is not precluded by any of the claim language.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 5712723672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights